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N/A Completed N=45 Randomized Quadruple-blind Treatment

Minnesota Community-Based Cognitive Training in Early Psychosis

Schizophrenia · Psychosis · schizoaffective disorder · Schizophreniform Disorders
Source: ClinicalTrials.gov NCT03079024 ↗
Enrolled (actual)
45
Serious AEs
13.3%
Results posted
Jan 2025
Primary outcomePrimary: Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) — 41.75; 41.2; 24.82 T-score

Summary

The purpose of this study is to determine whether cognitive training exercises can improve cognitive functioning in young patients with recent-onset psychosis who are being treated in community mental health settings using the NAVIGATE model. The investigators will examine the effects of web-based cognitive training exercises delivered on iPads. Participants will be randomized to one of three conditions, and will be assessed at Baseline, Post-Intervention, and 6 Month Follow Up on measures of clinical, neurocognitive, and functional status.

Outcome Measures

OutcomeResultp-value
PRIMARY
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
48.4; 40.56; 51.5
PRIMARY
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
48.4; 40.56; 51.5
PRIMARY
Speed of Processing From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
48.4; 40.56; 51.5
PRIMARY
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
40.6; 37.5; 39.5
PRIMARY
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
40.6; 37.5; 39.5
PRIMARY
Attention From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
40.6; 37.5; 39.5
PRIMARY
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.75; 41.91; 43.8
PRIMARY
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.75; 41.91; 43.8
PRIMARY
Working Memory From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.75; 41.91; 43.8
PRIMARY
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.67; 42.73; 46.2
PRIMARY
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.67; 42.73; 46.2
PRIMARY
Verbal Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.67; 42.73; 46.2
PRIMARY
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
44.4; 42.89; 47
PRIMARY
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
44.4; 42.89; 47
PRIMARY
Visual Learning From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
44.4; 42.89; 47
PRIMARY
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
49.3; 42.11; 44.5
PRIMARY
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
49.3; 42.11; 44.5
PRIMARY
Problem Solving From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
49.3; 42.11; 44.5
PRIMARY
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.75; 44.73; 52.6
PRIMARY
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.75; 44.73; 52.6
PRIMARY
Social Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
43.75; 44.73; 52.6
PRIMARY
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
41.6; 39.63; 45
PRIMARY
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
41.6; 39.63; 45
PRIMARY
Global Cognition From the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB)
41.6; 39.63; 45
PRIMARY
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
34.9; 32.71; 33.5
PRIMARY
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery Neurobehavioral Test Battery
37.94; 39.64; 37.8
PRIMARY
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
41.1; 43.29; 41
PRIMARY
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
34.9; 32.71; 33.5
PRIMARY
Emotion Recognition From the University of Pennsylvania Computerized Neurobehavioral Test Battery
34.9; 32.71; 33.5
PRIMARY
Emotional Prosody Identification From the University of Pennsylvania Computerized Neurobehavioral Test Battery
41.1; 43.29; 41
PRIMARY
Faux Pas Test Theory of Mind
82.36; 89.39; 91.67
PRIMARY
Faux Pas Test Theory of Mind
82.36; 89.39; 91.67
PRIMARY
Faux Pas Test Theory of Mind
82.36; 89.39; 91.67
PRIMARY
Quality of Life Scale-Abbreviated (Functioning)
4.25; 3.66; 4.67
PRIMARY
Quality of Life Scale-Abbreviated (Functioning)
4.25; 3.66; 4.67
PRIMARY
Quality of Life Scale-Abbreviated (Functioning)
4.25; 3.66; 4.67
PRIMARY
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
166.44; 103.67; 99.2
PRIMARY
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
166.44; 103.67; 99.2
PRIMARY
Auditory Processing Speed From the Posit Science Sound Sweeps Assessment
166.44; 103.67; 99.2
PRIMARY
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
4.25; 4.17; 4.42
PRIMARY
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
4.25; 4.17; 4.42
PRIMARY
Temporal Experience of Pleasures (TEPS):Reward Sensitivity--Anticipatory Pleasure
4.25; 4.17; 4.42
PRIMARY
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
4.89; 4.78; 4.93
PRIMARY
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
4.89; 4.78; 4.93
PRIMARY
Temporal Experience of Pleasures (TEPS): Reward Sensitivity--Consummatory Pleasure
4.89; 4.78; 4.93
PRIMARY
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
41.32; 36.31; 38.39
PRIMARY
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
41.32; 36.31; 38.39
PRIMARY
Verbal Memory: Delayed Recall From the Hopkins Verbal Learning Test-Revised Version (HVLT-R)
41.32; 36.31; 38.39
PRIMARY
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
48.67; 48.16; 46.89
PRIMARY
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
48.67; 48.16; 46.89
PRIMARY
Visual Memory: Delayed Recall From the Brief Visuospatial Memory Test-Revised Version (BVMT-R)
48.67; 48.16; 46.89
SECONDARY
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
67.86; 69.42; 30.1
SECONDARY
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
67.86; 69.42; 30.1
SECONDARY
UCSF Performance-Based Skills Assessment (UPSA): Functional Capacity
67.86; 69.42; 30.1
SECONDARY
Social Functioning Scale
112.43; 107.58; 121.09
SECONDARY
Social Functioning Scale
112.43; 107.58; 121.09
SECONDARY
Social Functioning Scale
112.43; 107.58; 121.09
SECONDARY
Internalized Stigma of Mental Illness (ISMI)
1.74; 2.14; 1.46
SECONDARY
Internalized Stigma of Mental Illness (ISMI)
1.74; 2.14; 1.46
SECONDARY
Internalized Stigma of Mental Illness (ISMI)
1.74; 2.14; 1.46

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, major depressive disorder with psychotic features, bipolar disorder with psychotic features, psychosis disorder not otherwise specified, or unspecified schizophrenia spectrum disorder, and started receiving treatment services at a First Episode Psychosis Program within the last two years
  • Good general physical health
  • Aged between 16 and 35 years (inclusive)
  • Fluent in spoken and written English
  • No neurological disorder (diagnosis of Autism Spectrum Disorder is allowed)
  • Achieved clinical stability, defined as outpatient status for at least one month prior to study participation, stable doses of psychiatric medications for at least one month prior to study participation
  • Women who are pregnant or breastfeeding may participate in this study.

Exclusion Criteria

  • Unable to provide informed consent
  • Participated in significant cognitive training programs within the last three years
  • Clinically significant substance abuse that is impeding the subject's ability to participate fully during recruitment, assessment, or training (is unable to remain sober for assessments and training).
  • Prescribed >0.5mg daily benztropine (Congentin), >25mg daily diphenhydramine, or high doses of clozapine (>500 mg po qd) or olanzapine (to be determined on a case by case basis).
  • Active suicidal ideation at screening or baseline, or previous intent to act on suicidal ideation with a specific plan, preparatory acts, or an actual suicide attempt within the last 6 months, as indicated by the C-SSRS
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03079024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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